Actively Recruiting

Phase 4
Age: 21Years - 75Years
All Genders
Healthy Volunteers
NCT06690164

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone

Led by National University Hospital, Singapore · Updated on 2025-07-02

78

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a 2-arm, prospective, randomized, parallel-group, open-label, longitudinal study that lasts 30 days for each study participant. This study aims to investigate the effect of co-administration of Omeprazole with Atorvastatin versus Atorvastatin monotherapy on atorvastatin lactone level. Primary endpoint: Higher statin lactone level in intervention arm after 30 days. Secondary endpoints: Higher hs-CRP in intervention arm Lipid panel Incidence of adverse drug side effects (e.g. muscle-related or elevated LFTs

CONDITIONS

Official Title

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males between 21 and 75 years old or females between 50 and 75 years old
  • No contraindications to the use of Atorvastatin and Omeprazole
  • Ability to comply with study requirements such as taking Atorvastatin and Omeprazole once daily and returning for follow-up after 1 month
  • Capable of understanding the study requirements and providing informed written consent
  • Have not taken any statins or proton pump inhibitors in the past 30 days
Not Eligible

You will not qualify if you...

  • Women of child-bearing age (younger than 50 years old)
  • Pregnancy, planning to conceive, or breastfeeding
  • Current or recent history of liver disease, kidney problems, muscle disease, or rhabdomyolysis
  • Recent history of alcohol or drug abuse
  • Concurrent use of other drugs that may interact with Atorvastatin or Omeprazole, such as clopidogrel
  • Acute infection or illness
  • Allergy to any statins or proton pump inhibitors
  • Any medical condition that might affect safety or successful completion of the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National University of Singapore (NUS) MD6 Level 8

Singapore, Singapore

Actively Recruiting

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Research Team

J

Junietta Lim, Bachelor of Science (Pharmacy)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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